MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR— 510(k) K973863
Substantially EquivalentHi-Tronics Designs, Inc.
FDA 510(k) clearance K973863 for MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR, Substantially Equivalent on 1998-01-02. Applicant: Hi-Tronics Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- Hi-Tronics Designs, Inc.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Budd Lake, NJ, US
Recent devices under product code DXH
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